Repeated neural stem cell–delivered virotherapy for newly diagnosed high-grade glioma
A Phase I Study of Repeated Neural Stem Cell-Based Virotherapy and Standard Radiation and Chemotherapy for Newly Diagnosed High-Grade Glioma
This trial will test whether repeated doses of a neural stem cell–carried oncolytic virus (NSC-CRAd-S-pk7) are safe and feasible for adults newly diagnosed with high-grade glioma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06169280 on ClinicalTrials.gov |
What this trial studies
Participants undergo a diagnostic biopsy with an intraoperative injection of NSC-CRAd-S-pk7, then have tumor resection about two weeks later with a second intraoperative dose and placement of a catheter for subsequent dosing. Standard chemoradiotherapy (daily radiotherapy with concomitant temozolomide) begins after surgical recovery, with a third and fourth viral dose delivered through the implanted catheter timed during and at the end of radiotherapy; the formal DLT window begins with dose #3 because radiation activates the survivin promoter. Additional monthly doses are given through the catheter for a planned total treatment series, and patients are followed for safety, tumor response, time to progression, overall survival, and quality of life. The trial is a Phase 1, dose/feasibility-focused protocol conducted at a single center to characterize tolerability and preliminary signals of activity.
Who should consider this trial
Good fit: Adults (≥18 years) with newly diagnosed WHO grade 3 or 4 high-grade glioma whose tumor is accessible for injection, who plan to undergo standard chemoradiation, have WHO performance status < 2, and meet required laboratory and steroid criteria.
Not a fit: Patients with tumors in the brainstem or contained within the ventricular system, those unable to undergo biopsy/resection or standard chemoradiation, or those with poor performance status or significant organ dysfunction are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control and potentially extend progression-free and overall survival by delivering oncolytic virus directly to tumor sites.
How similar studies have performed: Early-phase trials of oncolytic viruses and some cell-carrier strategies have reported preliminary safety and occasional tumor responses, but repeated NSC-CRAd-S-pk7 delivery in this schedule is largely novel and has limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of a high-grade glioma (WHO grade 3 or grade 4). * Patients must have presumed high grade glioma (WHO grade 3 or 4) based on clinical and radiologic evaluation for registration. * A pathologic confirmation of high grade glioma must be made at the time of stereotactic biopsy prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study). * Tumor must be accessible for injection and must not be located in the brainstem or contained within the ventricular system. * Planning to undergo standard radiation/chemotherapy. * 18 years of age or older. * Performance status (PS) must be WHO PS of \< 2. * Stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg/day for the 5 days prior to inclusion * Serum glutamic-oxaloacetic transaminase (SGOT or AST) \< 3x upper limit of normal * Serum creatinine \< 2mg/dl * Platelets \> 100,000/mm3 and white blood cells (WBCs) \> 3000/mm3 Exclusion Criteria: * Prior or ongoing liver disease including known cirrhosis. * Known hepatitis B or C infection, known HIV infection. * Chronic use of immunosuppressive drugs (with exception of corticosteroids required for mass effect). * Acute viral, bacterial or fungal infections requiring therapy. * Pregnant or breast-feeding patients. * Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers). * Prior radiation therapy to the brain or prior treatment for brain tumor.
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Roger Stupp, MD — Northwestern University
- Study coordinator: Neurological Surgery
- Email: braintumortrials@nm.org
- Phone: (312) 695-8143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.